1 purpose! Novartis expands its early development and innovative CAR-T cell therapy manufacturing capabilities in its newly launched Center of Excellence, located in the East Hanover, NJ campus. Our therapies are being developed as transformative treatments with life-saving potential for various B cell malignancies and other oncological diseases. We look to be bold with purpose, as we reimagine medicine and lead the way in advancing scientific breakthroughs for patients.
The Senior Manager, Science & Technology (Bioanalytics) will coordinate and lead all activities to ensure the timely testing/release of all samples, set up laboratory planning to improve efficiency/throughput, lead the execution of validation and other major projects to assure GMP beyond compliance related to development/clinical operations at our Cell and Gene Therapy GMP facility! They will lead a group of lab associates and provide employees with training and resources to meet or exceed requirements. As the subject matter expert on specific areas and techniques, they will deliver quality products and services on time to all customers (internal and external); all while supervising processes and products to find opportunities for continuous improvements.
**Onsite 100% is required for this position. The schedule for this role is Wednesday - Saturday 4/10 hour days **
Your responsibilities will include, but are not limited to:
• Supervise, lead and perform scheduling of bioanalytical testing such as Flow, cell count, cell viability, Potency and qPCR following appropriate protocols, test methods, and compendia (United States Pharmacopoeia (USP), American Chemical Society (ACS)). Ensure all samples and reagents have been prepared, tested or inspected according to specifications and current testing. Assure qualification status of critical reagents.
• Primary point of contact for troubleshooting / Communication to Management during shifts. Organizes plans and provides support to the team members in any analytical/technical questions and problems, in order to ensure efficiency and accountability of the group. • Lead and perform OOS/OOE investigations, deviation investigation /CAPA implementation and ensure timely closure. Evaluates/troubleshoots routine and non-routine technical and analytical problems and assists other laboratories and/or manufacturing in specific investigations. Handle change control and ensure timely closure.
• Supports the development, revision, application, maintenance, validation and review of quality standards, documents and methods for processing and/or ensuring quality in intermediates or finished products. Review and approval of batch documentation. Ensure conformance to in-house specifications and GMPs. Maintain all test methods and specifications compliant with current USP/NF.
• Possess CSV validation experience/documentation experience. Authors method validation protocols and reports. Performs method revision and validation as well as assisting with method development Authors new and revises existing standard operating procedures to ensure compliance. Perform review and release of test work. Leads method revision and transfers.
• Execute periodic, mid-year/year-end performance appraisals for direct reports. Leads training of new associates. Provides feedback (formal and informal) to team members on routine basis. Perform other duties as assigned.
• Work on shifts covering daytime / evening and one or both weekend days. Ability to work different shift, weekends and overtime will be required. Your shift will be fixed according to business need.
• Knowledge and familiarity of SAP systems, including Quality Module (QM), LIMS systems (Labware LIMS), Trackwise, and familiarity of eSOPS and TEDI. Drive 5S and lean projects. Leads optimization of test procedures to improve efficiency whenever possible.
Diversity & Inclusion / EEO
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.
What you'll bring to the role:
• Education: Bachelors in biology, chemistry, biochemistry, microbiology or other related science. (Advanced degree preferred).
• Minimum of 8 years’ experience in the pharmaceutical/Biotechnology industries conducting QC testing, release testing and coordinating the activities of a QC laboratory.
• Minimum of 3 years of people management experience.
• Knowledge of cGMP, USP and FDA guidelines.
• Strong written and verbal communication skills.
• Detail-oriented with expertise in problem solving and solid decision-making abilities.
• Position will be filled at level commensurate with experience.
The pay range for this position at commencement of employment is expected to be between $102,400 and $153,600/year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
Imagine what you could do here at Novartis!
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
Accessibility and reasonable accommodations
The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] call +1 (877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.